CHPA announces support of ONDCP media campaign appropriation 

CHPA President Linda A. Suydam, D.P.A., wrote to the chairman of the House Appropriations Subcommittee on Transportation, Treasury, and Related Agencies April 18 in support of the administration's fiscal year 2004 budget request of $170 million for the Office of National Drug Control Policy's (ONDCP's) National Youth Anti-Drug Media Campaign. "We believe that [the media campaign] is an important and effective tool to prevent substance abuse in teenagers," Suydam affirmed in her letter to Chairman Ernest Istook, Jr. Citing research that indicates teenagers who see the anti-drug ads have stronger anti-drug attitudes and are less likely to use drugs than those teens with little to no exposure to the ads, Suydam pointed out that "the administration's request for $170 million will help improve the public health of our nation." 

The National Youth Anti-Drug Media Campaign was launched in 1998 and was authorized for a five-year period. Using appropriated funds, it combines paid commercial advertising (such as the public service announcement above), grassroots public outreach, and other supporting communications efforts. The campaign also operates www.Freevibe.com, designed for youth, and www.TheAnti-Drug.com for parents, as well as several specialized web sites such as www.LaAntiDroga.com, for Spanish-speaking parents.

CHPA contacts: Kevin Kraushaar and Dr. Linda Suydam

Back to the top

CHPA Logistics Steering Committee moves forward

Selects chairman, establishes mission, and organizes subcommittees 

Tom Long, vice president, operations, The Mentholatum Company, has been selected as chairman of the CHPA Logistics Steering Committee established earlier this year. Subcommittees and chairs also have been organized to work on issues identified at the full-committee meeting held in January.

• Rick Weisbrod, vice president, operations, Del Laboratories, Inc., will lead the team exploring best practices on customization.

• Bob Wigmore, vice president, supply chain logistics, Wyeth Consumer Healthcare, will head up the subcommittee addressing opportunities for data-synchronization.

• Scott Zellner, vice president, operations, Johnson & Johnson Sales & Logistics Company, will direct the group focused on the industry-wide RFID/Auto-ID initiative. 

Weisbrod		Wigmore		Zellner

The goals of the subcommittees stem from the committee’s newly defined mission: “The Logistics Steering Committee considers matters relating to supply chain and distribution issues as they uniquely relate to the consumer healthcare products industry and develops programming to inform and educate CHPA members about emerging technology, opportunities, and business practices in the logistics arena.” 

For a complete roster of CHPA Logistics Steering Committee members and CHPA staff liaisons, please click here. 

The committee will keep the full membership apprised as it accomplishes its work. 

CHPA contact: Ted Peterson

Back to the top

FDA issues final rule and proposed amendment on antidiarrheal drugs

In its ongoing effort to finalize OTC monographs, FDA issued a final rule April 17 on OTC antidiarrheal drug products. This final rule changes the classification of some antidiarrheal active ingredients included in the 1986 tentative final monograph.

• Attapulgite, calcium polycarbophil, and polycarbophil have been reclassified from proposed category I to nonmonograph status because of insufficient effectiveness data. 

• Bismuth subsalicylate has been reclassified from category III to a monograph ingredient, but the indication of prevention of travelers' diarrhea was rejected. In a proposed amendment issued the same day, FDA proposes to allow the claim that bismuth subsalicylate can relieve travelers’ diarrhea. FDA stipulates in the proposal, however, that manufacturers may not include this indication on labels until such time as the Agency publishes a final rule on the subject. 

• Kaolin, formerly classified as category III, is a monograph ingredient in this final rule. Other active ingredients—including bismuth subnitrate, calcium hydroxide, activated charcoal, pectin, potassium carbonate, and rhubarb fluidextract—are nonmonograph antidiarrheals in this rule.  

The Agency considered data supplied by manufacturers, as well as the recommendations of a 1993 advisory panel to come to its determinations. FDA has identified 45 manufacturers currently marketing 383 OTC antidiarrheal drug products containing bismuth subsalicylate, attapulgite, kaolin and pectin, polycarbophil, and calcium polycarbophil and determines that this final rule will require the reformulation or removal of roughly 50 products. 

FDA also included some labeling changes in the rule, and specifically solicits comments on them. 

Manufacturers must be in compliance with the rule by April 17, 2004; products with sales less than $25,000 have an additional year to comply. 

CHPA contact: Dr. Lorna Totman

Back to the top

FDA issues a final rule on Reye’s syndrome

FDA issued a final rule April 17 on Reye’s syndrome warnings on OTC products containing aspirin and nonaspirin salicylates. This rule applies to all oral and rectal OTC drug products containing salicylates as active ingredients, including bismuth subsalicylate-containing products for over-indulgence and those covered in the just-published final monograph on antidiarrheal OTCs. (See previous story.)  While the rule’s effective date is one year from issuance, the compliance date for products under the monographs for OTC internal analgesic, antipyretic, and antirheumatic drugs, and for menstrual drug products, will be established when those monographs are finalized. 

By issuing this rule, FDA is seeking to make Reye’s syndrome labeling for all aspirin- and nonaspirin salicylates-containing OTCs consistent. This rule revises the Agency’s previous regulation and requires that the warning not only inform consumers that children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not be given these products, but also that the warning provide consumers with more information on the early symptoms of the syndrome. The rule clarifies that nonaspirin salicylates used as inactive ingredients are not covered by the warning. 

Products with bismuth subsalicylate must be in compliance with the rule by April 19, 2004; products with sales less than $25,000 have a compliance date of April 18, 2005. OTCs under a new drug application with aspirin or nonaspirin salicylates must be in compliance by October 18, 2004.

CHPA contact: Dr. Lorna Totman

Back to the top

NDAC to look at syrup of ipecac

FDA announced April 11 on its advisory committee hotline that it will consider the safety and efficacy of OTC ipecac syrup at the next meeting of the Nonprescription Drugs Advisory Committee (NDAC). Ipecac syrup is indicated for emergency use to cause vomiting in the event of certain poisonings. According to the recorded telephone message, the NDAC panel will focus on the following five issues:

1. The role of syrup of ipecac in gastrointestinal decontamination;
2. The literature describing the risk-benefit ratio of using ipecac syrup;
3. The role of the product among populations with limited access to emergency medical treatment;
4. Significant abuse of the ingredient, if it exists; and
5. Alternative therapies that may be available.

The June 12 meeting will convene at the Holiday Inn in Bethesda, Maryland, at 8 a.m. The public hearing portion of the meeting will commence at 1 p.m. To listen to the FDA advisory committee hotline message in its entirety, call (800) 741-8138; the five-digit NDAC code is 12541. 

CHPA contact: Dr. Lorna Totman

Back to the top

Legal reform passes Senate Judiciary Committee

The Senate Judiciary Committee has approved the Class Action Fairness Act of 2003, clearing the way for it to be heard by the full Senate. The bill, endorsed by CHPA, would help prevent trial lawyers from “forum shopping” by easing the rules for removing class action cases from state to federal courts.

Under the bill, class action lawsuits would automatically be moved to the federal court system if the total claims in a suit were to exceed $5 million. Class action suits also could be removed to the federal court system if fewer than one-third of the plaintiffs were from the same state as the primary defendant, or if between one-third and two-thirds of plaintiffs were from the same state as the primary defendant and a federal judge were to decide that the case should be removed.

Before approving the bill, the committee adopted an amendment sponsored by Senators Arlen Specter (R-Penn.) and Diane Feinstein (D-Calif.) that removed bill language that would have allowed so-called ‘private attorney general suits’ to be pushed to federal courts. While these cases are not class action lawsuits, they are brought by plaintiffs who claim to act in the best interest of the general public. Feinstein said that the language was a “direct strike” against California law, which allows such cases.

It is unclear when the Senate will address the bill. Similar legislation is pending in the House Judiciary Committee. 

CHPA contact: Kevin Kraushaar

Back to the top

FDA corrects the cough/cold combination product final monograph

The April 14 Federal Register included a correction to the cold, cough, allergy, bronchodilator, and antiasthmatic drug products final monograph for OTC combination products. The notice corrects the dosage interval instructions for affected products. 

Back to the top

ODS plans for the future

The National Institutes of Health’s Office of Dietary Supplements (ODS) announced in the April 10 Federal Register that it is re-examining its original strategic plan in order to develop an updated five-year plan. ODS pointed out in the notice that yearly budget increases have allowed it to progress considerably in its work and to expand its programs. Soliciting comments from stakeholders, ODS specifically invites perspectives on its overarching goals, as well as its specific objectives and the approaches the office uses to address its goals and objectives. In addition, ODS will hold a public meeting in Bethesda, Maryland, May 8-9, for more input. Information on the meeting, how to participate, and background details on the office’s goals and objectives are available on the ODS web site. 

CHPA contact: Dr. Lorna Totman

Back to the top

Manufacturing subcommittee announces meeting

The Manufacturing Subcommittee of the FDA Advisory Committee for Pharmaceutical Science announced in the April 14 Federal Register that it will hold its next meeting May 21-22. The meeting will take place in Gaithersburg, Maryland. 

Agenda items of note include discussion of the subcommittee's mission; the direction of the Agency's current Good Manufacturing Practices initiative (See February 21 XNL and August 30, 2002, XNL); regulatory approaches regarding aseptic manufacturing; and process analytical technologies, including the transition of the work of the disbanded Process Analytical Technologies Subcommittee to the manufacturing subcommittee. 

CHPA contact: Fred Razzaghi

Back to the top

CHPA staff travel inside the Beltway and beyond

Donna Edenhart, director of public affairs, attended a press conference March 15 in Arlington, Virginia, at which the Drug Enforcement Administration (DEA) disclosed the results of an 18-month investigation involving the trafficking of bulk pseudoephedrine intended for the illicit manufacture of methamphetamine. DEA announced that the mission, dubbed “Operation North Star,” culminated in the arrest of over 50 individuals within Canada and the United States and the seizure of 39,000 pounds of bulk pseudoephedrine. In addition to the DEA, the press conference also included statements from the Royal Canadian Mounted Police, the Federal Bureau of Investigation, and the Internal Revenue Service...

Ted Peterson, vice president, corporate development, met with Gregory C. Pulido of Humco Holding Group, in Texarkana, Texas, April 1. Pulido is the chairman of CHPA’s Business Development Committee and they met to discuss initiatives that came out of the committee's March 13 meeting...

CHPA’s Fred Razzaghi, director, technical affairs, and Lorna Totman, Ph.D., senior director of scientific affairs and toxicology, attended Temple University School of Pharmacy’s fourth annual FDA-Industry Conference April 15. The Philadelphia, Pennsylvania, conference was entitled “Creating New Knowledge: Enhancing the Scientific Approach to QA and RA Issues,” and featured Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research, and Bruce Burlington, M.D., executive vice president, quality, regulatory and safety, Wyeth Consumer Healthcare. Risk management, systems inspections, FDA’s Good Manufacturing Practices initiative, and process analytical technologies were all on the agenda… 

Back to the top

R&SDC is now RSC

CHPA's Scientific Affairs Committee has changed the name of the Association's yearly scientific conference. Gone will be the tongue-twisting Research and Scientific Development Conference, or R&SDC. This year's educational offering will be called, more simply, the Regulatory and Scientific Conference, or RSC. Planning is well underway for this significant event, which will take place November 6-7 in Washington, D.C. Stayed tuned as speakers are shored up and the agenda is fine tuned.

Back to the top

Agency announces the dates of its 9th Annual FDA Science Forum

FDA will conduct its 2003 Science Forum April 24-25. According to the Agency, "the Science Forum is FDA's key scientific meeting that seeks to communicate and promote scientific issues relating to scientific development and associated regulatory concerns." The conference will delve into risk management and assessment issues, as well as FDA science initiatives and their impact on policy and the ramifications of the September 11 tragedy. The meeting—which will take place at the new Washington Convention Center in Washington, D.C.—is open to the public. More information is available online.

Back to the top

AAPS to hold particle size workshop

The American Association of Pharmaceutical Scientists (AAPS) announces it will conduct a workshop on particle size issues in conjunction with the Product Quality Research Initiative (PQRI) and USP. The workshop will cover numerous areas of particle size analysis, from fundamentals of particles to the characterization and measurement of particle size. The April 30-May 2 workshop will take place in Arlington, Virginia. More information can be found on the AAPS web site. 

Back to the top

FDA/Industry Summer Workshop
June 16, 2003
Sheraton Meadowlands
East Rutherford, New Jersey

FDA/Industry Summer Workshop
July 14, 2003
San Juan Marriott Resort & Stellaris Casino
San Juan, Puerto Rico

FDA/Industry Summer Workshop
August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

CHPA MarketPlace 2003
September 18, 2003
Hilton East Brunswick
13 Tower Center Blvd.
East Brunswick, New Jersey

Manufacturing Controls Seminar
October 9-10, 2003
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

Regulatory and Scientific Conference
November 6-7, 2003
The Fairmont Washington
2401 M Street, NW
Washington, D.C.

Back to the top